Monitoring, safety and shortages
Your responsibilities do not stop once your therapeutic good is on the market. Please find information below about further monitoring of your product, reporting adverse events and shortages.
Latest alerts
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Gold Max Blue capsules pose a serious risk to your health and should not be taken.
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We have become aware of an increasing number of cases of liver injury reported in scientific literature, by consumers who had taken products containing Garcinia gummi-gutta.
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The TGA has received reports of serious adverse events in infants and children who have been given compounded wind and colic preparations containing Atropa belladonna (belladonna).
Latest articles
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Recall reforms update and new procedure
Recall reforms program update and preview of the PRAC Version 1.0. -
Elemental impurities in traditional Chinese medicines (TCMs)
TCMs sold in Australia are carefully regulated to ensure safety and quality. -
TGA's decision to not register lecanemab (LEQEMBI)
TGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).
Latest publications
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This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
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This web publication constitutes a notice for the purposes of regulations 42ZCZS and 42ZCZX of the Therapeutic Goods Regulations 1990 (the Regulations).
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Find out about the seasonal influenza vaccines available for the 2024 southern hemisphere season.
Resources
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We have adopted this International Scientific Guideline – ICH Q5A(R1); CPMP/ICH/295/95
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A resource for sponsors conducting market actions for therapeutic goods in Australia.
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We have adopted this International Scientific Guideline – ICH E15; EMEA/CHMP/ICH/437986/2006
Latest consultations
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This consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
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The TGA sought feedback from interested parties on proposed changes to the requirements of ingredients used in listed (low-risk) medicines.
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Have your say about proposed changes to address 3 medicine safety matters needing action, before we review labelling rules more broadly.